National Database of the Virtual Institute of Cerebrovascular Diseases

NCT05925699 | Not Yet Recruiting

• 1 other identifier: 5832
• Study Type: observational
• Target: 285,600
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to develop a national registry of cerebrovascular diseases in order to define the subtypes of these diseases associated with a worse prognosis. Secondly, the study aims to find clinical, radiological, and biological markers capable tof predicting the outcome of cerebrovascular diseases and the onset of complications related to therapeutic procedures, and to calculate predictive prognostic scores composed of multiple variables. Each participating center will collect clinical, radiological, and biological data from the medical records of the study participants. Patients included in the study will not undergo any additional medical procedures to those of normal clinical practice.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• Identification of subtypes of each cerebrovascular disease (ICD-9 430-438) associated with poor prognosis.

  Identification and definition of the various subtypes of each cerebrovascular disease (International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438) associated with poor prognosis.

  July 1, 2023 - July 1, 2053

Secondary Outcomes (20)

• Identification of clinical variables of each cerebrovascular disease correlated with its prognosis

  July 1, 2023 - July 1, 2053

• Identification of radiological variables of each cerebrovascular disease correlated with its prognosis

  July 1, 2023 - July 1, 2053

• Identification of biomarkers of each cerebrovascular disease correlated with its prognosis

  July 1, 2023 - July 1, 2053

• Identification of neurophysiological variables of each cerebrovascular disease correlated with its prognosis

  July 1, 2023 - July 1, 2053

• Identification of prognostic scores for each cerebrovascular disease

  July 1, 2023 - July 1, 2053

Study Arms (1)

All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049

Other: Collection of clinical, radiological, and biological data from patients' medical records

Interventions

Collection of clinical, radiological, and biological data from patients' medical records OTHER

Collection of clinical, radiological, and biological data from patients' medical records

All patients with new-onset cerebrovascular disease from January 1, 2016 to July 1, 2049

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with cerebrovascular diseases occuring between January 1, 2016 and July 1, 2049 who consented to partecipate in the study

You may qualify if:

• Diagnosis of cerebrovascular pathology defined according to the NINDS special report of 1990 as "all disorders in which there is an area of the brain transiently or permanently affected by ischemia or bleeding and/or in which one or more blood vessels of the brain are mainly altered by a pathological process", falling within the following codes of the International Classification of Diseases, 9th revision (ICD-9): ICD-9 430-438;
• Informed consent provided by the patient or his legal representative in the case of mental incapacity or by the parents/guardians in the case of minors.

You may not qualify if:

• The patient, his legal representative in the case of mental incapacity or his parents/guardians in the case of minors clearly state their will to leave the study;
• Onset of cerebrovascular disease before January 1, 2016.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Humanitas Hospital, Italy: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• I.R.C.C.S. Fondazione Santa Lucia: collaborator
• Ospedale Policlinico San Martino: collaborator
• IRCCS San Camillo, Venezia, Italy: collaborator
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• Ospedale Pediatrico Bambin Gesù: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• IRCCS Fondazione Stella Maris: collaborator
• Istituto Neurologico Mediterraneo Neuromed S. R. L: collaborator
• IRCCS San Raffaele Roma: collaborator
• Ospedale San Raffaele: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Istituto Auxologico Italiano: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Fondazione IRCCS San Gerardo dei Tintori: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Related Publications (6)

• Special report from the National Institute of Neurological Disorders and Stroke. Classification of cerebrovascular diseases III. Stroke. 1990 Apr;21(4):637-76. doi: 10.1161/01.str.21.4.637. No abstract available.

  PMID: 2326846 RESULT

• Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.

  PMID: 35016208 RESULT

• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 RESULT

• Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.

  PMID: 21557809 RESULT

• Ozpinar A, Mendez G, Abla AA. Epidemiology, genetics, pathophysiology, and prognostic classifications of cerebral arteriovenous malformations. Handb Clin Neurol. 2017;143:5-13. doi: 10.1016/B978-0-444-63640-9.00001-1.

  PMID: 28552158 RESULT

• Ferro JM, Aguiar de Sousa D. Cerebral Venous Thrombosis: an Update. Curr Neurol Neurosci Rep. 2019 Aug 23;19(10):74. doi: 10.1007/s11910-019-0988-x.

  PMID: 31440838 RESULT

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Paolo Calabresi, Prof, MD

CONTACT

+390630154459; paolo.calabresi@policlinicogemelli.it

Irene Scala

CONTACT

+393519746393; irene.scala01@icatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Neurology Department

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 29, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2052
• Study Completion (Estimated): September 1, 2052
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

IT (1)